Lpath Inc. focuses on lipidomics-based therapeutics for treating a wide range of human diseases. The company today announced positive data from its dose-escalation phase I clinical trial of the investigational drug ASONEP(TM) in cancer patients with various solid tumors.
The study demonstrated that lymphocyte counts (the number of cells present in blood and lymphatic tissue) in the vascular space were reduced in a dose-related fashion, which led Lpath to achieve the objective established by Merck KGaA (Darmstadt, Germany), resulting in a $2 million payment per the license agreement with Merck KGaA.
Results also show that the study met its primary endpoint, successfully identifying safe dose levels for the phase II setting. ASONEP was well tolerated at all three dose-levels studied.
“These phase 1 results with ASONEP are encouraging. The safety of ASONEP as demonstrated in this study allows for its evaluation as a single agent or in combination with standard therapies without expectation of significant overlapping toxicities. This safety profile, along with the observation of stable disease in several late-stage cancer patients, provides strong justification for investigation of ASONEP in phase II clinical trials,” Michael Gordon, M.D., the principal investigator in the phase I trial, stated in the press release.
Scott R. Pancoast, Lpath president and CEO, said the study’s achievements signal ASONEP’s potential in the market.
“Our phase I trial further validates our novel approach of targeting bioactive signaling lipids and underscores the potential of our ImmuneY2(TM) drug-discovery engine. Moreover, achievement of the milestone provides evidence that ASONEP is having the expected pharmacological effect in human subjects, which is important with a first-in-class drug candidate,” Pancoast stated.
Dr. Gordon will present additional results of the trial at the annual meeting of the American Society of Clinical Oncology in Washington, D.C. June 7, 2010.